Sensory Abnormalities in Post-surgical Peripheral Neuropathy
CompletedNCT03966677
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a "true" pathological condition but could also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition. The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity, and gender. Normative reference intervals are certainly of help, particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring "false" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject is impressive 46% (\[1 - 0.95\^10\] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.
Study details
- Official title
- Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data
- Conditions
- Sponsor
- University of Copenhagen
- Start date
- 2019-07-01
- Primary completion
- 2022-06-28
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
INCLUSION CRITERIA: All study subjects must meet all the following criteria to be eligible to enroll in the study: * Age above 18 yrs and below 65 yrs * Signed informed consent * Body mass index (BMI): 18 \< BMI \< 35 kg/m\^2 * ASA I-II In addition, for study subjects without pain after GHR (NP-GHR): * having undergone uncomplicated, elective, unilateral open GHR a.m. Lichtenstein * no restriction in ADL-functions due to the GHR * activity-related groin pain \< 3 (numerical rating scale \[NRS\]: 0 = no pain, 10 = worst imaginable pain) EXCLUSION CRITERIA: Any study subject, who meets one or more of the following criteria, is not suitable for inclusion in this study: * do not speak or understand Danish * who cannot cooperate with the investigation * abuse of alcohol or drugs - according to investigator's evaluation * use of psychotropic drugs (exception of SSRI) * neurologic or psychiatric disease * chronic pain condition * regular use of analgesic drugs * skin lesions or tattoos in the assessment areas (groins, lower arm) * nerve lesions in the assessment sites (e.g., after trauma, abdominal surgery) In addition, for healthy non-operated study subjects (NP): * subjects, who have had previous surgery in or near the groin region * use of prescription drugs one week before the trial * use of over-the-counter (OTC) drugs 48 hours before the trial * experiencing pain at rest \> 3 (NRS) * experiencing activity-related pain in or near the groin \> 3 (NRS) In addition, for study subjects without pain after GHR (NP-GHR): * experiencing pain at rest \> 3 (NRS) * experiencing activity-related pain in or near the groin \> 3 (NRS)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03966677